Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions (LIPA-DRAIN)

March 9, 2021 updated by: Centre Hospitalier Universitaire Dijon

Surgery is the principal treatment for benign and malignant pancreatic tumours. This surgery can be accompanied by complications among which the main one is pancreatic fistula, which leads to the flow of pancreatic juices into the abdominal cavity. Depending on its severity, a fistula can be managed medically, with the implantation of a la pose d'un percutaneous drain, endoscopic treatment, or revisit surgery. It has been shown that early management of the fistula prevents it from evolving towards major complications such as haemorrhage or serious intra-abdominal infections.

To date, the early diagnosis of pancreatic fistula is based on high levels of one pancreatic enzyme, amylase, in the drains. However in certain clinical situations, patients present post-operative fistulas with no elevation of amylase. And, on the contrary, increased amylase with no clinical consequences.

It is therefore necessary to identify another early early marker of pancreatic fistula that corresponds better to clinical signs.

In a preliminary study conducted in 65 patients, the investigators recently found that another pancreatic enzyme (lipase) could be a more pertinent marker of pancreatic fistula, but this requires confirmation in a greater number of patients.

The objective is to evaluate the diagnostic performance of lipase in the drains for the early detection of pancreatic fistula with clinical repercussions in the 30 days following the surgery.

The study consists in collecting at 4 different time points (D1, D3, D4 and D6) a tube of blood and a tube of drain liquid.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

770

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25030
        • CHU Jean Minjoz
      • Chalon-sur-Saône, France, 71321
        • CHU William MOREY
      • Dijon, France, 21079
        • Chu Dijon Bourgogne
      • La Tronche, France, 38700
        • Chu Grenoble Alpes
      • Lille, France, 59037
        • Hôpital Claude Huriez
      • Lyon, France, 69317
        • HCL - Hôpital universitaire de la Croix Rousse
      • Marseille, France, 13009
        • APHM - Institut Paoli-Calmettes
      • Reims, France, 51100
        • CHU de Reims - Hôpital Robert Debré
      • Strasbourg, France, 67098
        • Hôpital Hautepierre
      • Vandoeuvre Les Nancy, France, 54511
        • Chu de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing scheduled pancreatic resection

Description

Inclusion Criteria:

  • Patients over 18
  • Patients undergoing scheduled pancreatic resection with or without anastomosis (cephalic duodenopancreatectomy, median pancreatectomy, left pancreatectomy, enucleation)
  • Patients able to understand instructions/information
  • Patients who have provided written informed consent
  • Patients with Health Insurance cover

Exclusion Criteria:

  • Patients with scheduled total pancreatectomy
  • Adults under wardship
  • Pregnant or breast-feeding women
  • Total pancreatectomy
  • Pancreatectomy not feasible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient
Biological: Lipase, amylase and CRP (C-reactive protein) dosages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dosage of lipase in the drains
Time Frame: 3 days after surgical resection
3 days after surgical resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2016

Primary Completion (Actual)

November 3, 2020

Study Completion (Actual)

November 3, 2020

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FACY PHRCI 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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